Sleep DisordersMelOptNCT07514507
Optimization of Melatonin Administration in Healthy Adults
A study testing Mel 2 mg 30 min, Mel 2 mg 3 h and Mel 4 mg 30 min in people with Sleep Disorders, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate whether the timing and dosage of exogenous melatonin can improve sleep onset and maintenance in healthy adults aged 18-45 years (50% female) with no history of sleep disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Mel 2 mg 30 min, Mel 2 mg 3 h and Mel 4 mg 30 min
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- May 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years of age
- Fluent knowledge of Italian language
- Review and signing of the informed consent form
Who cannot join
- Diagnosis of sleep or circadian rhythm disorder
- Diagnosis of neurological, psychiatric or medical condition that may interfere with sleep
- Ongoing treatment with medications that may affect sleep, including hypnotics and other types of melatonin
- Travel to a country with a time zone difference of at least two hours within the two months prior to or during the study
- Shift work
- Confirmed pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Pisa, Institute of Physiology, Sonnolab
Pisa, PI, 56126
Ugo Faraguna, MD, PhD, +39 050 2213470, ugo.faraguna@unipi.it
About this study
Official title: Optimizing Timing and Dose of Melatonin Administration: a Randomized, Double-blind Controlled Trial in Healthy Adults
The goal of this clinical trial is to evaluate whether the timing and dosage of exogenous melatonin can improve sleep onset and maintenance in healthy adults aged 18-45 years (50% female) with no history of sleep disorders.
The main questions it aims to answer is whether an optimized melatonin administration schedule (4 mg, 3 hours before bedtime) will be more effective in improving sleep initiation and maintenance than an administration schedule more commonly advised (2 mg, 30 minutes before bedtime).
Read more
Researchers will compare five conditions involving different combinations of melatonin or placebo administered 30 minutes or 3 hours before bedtime to see if earlier timing and/or higher dosage produces better sleep outcomes.
Participants will:
- Complete a habituation night without any intervention.
- Undergo five randomized, double-blind experimental sleep conditions including: 2 mg melatonin 30 minutes before bedtime 2 mg melatonin 3 hours before bedtime 4 mg melatonin 30 minutes before bedtime 4 mg melatonin 3 hours before bedtime Placebo at both time points
- Be monitored via polysomnography to measure sleep parameters
- Conditions
- Sleep Disorders
- Being tested
- Mel 2 mg 30 min, Mel 2 mg 3 h, Mel 4 mg 30 min, Mel 4 mg 3 h, Placebo
- Keywords
- melatonin, sleep health, sleep drugs, hypnotics and sedatives, drug administration schedule
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mel 2 mg 30 minDietary supplement
Melatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime
Mel 2 mg 3 hDietary supplement
Placebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime
Mel 4 mg 30 minDietary supplement
Melatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
Mel 4 mg 3 hDietary supplement
Placebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime
PlaceboOther
Placebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime
| Study group | Role | What they receive |
|---|---|---|
| 2mg 30min | Active comparator | Not described Receives: Dietary Supplement: Mel 2 mg 30 min |
| 2mg 3h | Experimental | Not described Receives: Dietary Supplement: Mel 2 mg 3 h |
| 4mg 30min | Experimental | Not described Receives: Dietary Supplement: Mel 4 mg 30 min |
| 4mg 3h | Experimental | Not described Receives: Dietary Supplement: Mel 4 mg 3 h |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency
Time required to fall asleep assessed using polisomnography
Measured: First night following administration of the drug
Secondary outcomes (3)
Total Sleep Time
Night sleep duration assessed using polisomnography
Measured: First night following administration of the drug
Sleep Efficiency
Ratio between total sleep time and time in bed
Measured: First night following administration of the drug
Wake After Sleep Onset
Minutes spent awake between the sleep onset and morning awakening
Measured: First night following administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514507
- Sponsor's protocol ID
- 0043072/2023
- Acronym
- MelOpt
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data cannot be shared publicly for the privacy of individuals who participated in the study
Publications
Bruno S, Cenerini G, Lo Giudice L, Cruz-Sanabria F, Benedetti D, Crippa A, Fiori S, Ferri R, Masi G, Faraguna U. Optimizing timing and dose of exogenous melatonin administration in neuropsychiatric pediatric populations: a meta-analysis on sleep outcomes. Sleep Med Rev. 2025 Dec;84:102158. doi: 10.1016/j.smrv.2025.102158. Epub 2025 Aug 30.
PubMed 40914024Cruz-Sanabria F, Bruno S, Crippa A, Frumento P, Scarselli M, Skene DJ, Faraguna U. Optimizing the Time and Dose of Melatonin as a Sleep-Promoting Drug: A Systematic Review of Randomized Controlled Trials and Dose-Response Meta-Analysis. J Pineal Res. 2024 Aug;76(5):e12985. doi: 10.1111/jpi.12985.
PubMed 38888087
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Timing and Dose of Melatonin Administration: a Randomized, Double-blind Controlled Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT07514507
- Acronym / sponsor ID
- MelOpt / 0043072/2023
- Conditions
- Sleep Disorders
- Keywords
- melatonin, sleep health, sleep drugs, hypnotics and sedatives, drug administration schedule
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether the timing and dosage of exogenous melatonin can improve sleep onset and maintenance in healthy adults aged 18-45 years (50% female) with no history of sleep disorders.
The main questions it aims to answer is whether an optimized melatonin administration schedule (4 mg, 3 hours before bedtime) will be more effective in improving sleep initiation and maintenance than an administration schedule more commonly advised (2 mg, 30 minutes before bedtime).
Researchers will compare five conditions involving different combinations of melatonin or placebo administered 30 minutes or 3 hours before bedtime to see if earlier timing and/or higher dosage produces better sleep outcomes.
Participants will:
- Complete a habituation night without any intervention.
- Undergo five randomized, double-blind experimental sleep conditions including: 2 mg melatonin 30 minutes before bedtime 2 mg melatonin 3 hours before bedtime 4 mg melatonin 30 minutes before bedtime 4 mg melatonin 3 hours before bedtime Placebo at both time points
- Be monitored via polysomnography to measure sleep parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2mg 30min | Active comparator | Dietary Supplement: Mel 2 mg 30 min |
| 2mg 3h | Experimental | Dietary Supplement: Mel 2 mg 3 h |
| 4mg 30min | Experimental | Dietary Supplement: Mel 4 mg 30 min |
| 4mg 3h | Experimental | Dietary Supplement: Mel 4 mg 3 h |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years of age
- Fluent knowledge of Italian language
- Review and signing of the informed consent form
Key exclusion criteria (7 listed)
- Diagnosis of sleep or circadian rhythm disorder
- Diagnosis of neurological, psychiatric or medical condition that may interfere with sleep
- Ongoing treatment with medications that may affect sleep, including hypnotics and other types of melatonin
- Travel to a country with a time zone difference of at least two hours within the two months prior to or during the study
- Shift work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mel 2 mg 30 minMelatonin 2 mg 30 minutes before bedtime, placebo 3 hours before bedtime | Dietary supplement | 2mg 30min |
| Mel 2 mg 3 hPlacebo administered 30 minutes before bedtime, melatonin 2 mg administered 3 hours before bedtime | Dietary supplement | 2mg 3h |
| Mel 4 mg 30 minMelatonin 4 mg administered 30 minutes before bedtime, placebo administered 3 hours before bedtime | Dietary supplement | 4mg 30min |
| Mel 4 mg 3 hPlacebo administered 30 minutes before bedtime, melatonin 4 mg administered 3 hours before bedtime | Dietary supplement | 4mg 3h |
| PlaceboPlacebo administered 30 minutes before bedtime, placebo administered 3 hours before bedtime | Other | Placebo |
Primary outcome
Sleep Onset Latency
Time frame: First night following administration of the drug
Time required to fall asleep assessed using polisomnography
3 secondary outcomes
Total Sleep Time
Time frame: First night following administration of the drug
Sleep Efficiency
Time frame: First night following administration of the drug
Wake After Sleep Onset
Time frame: First night following administration of the drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 40914024Bruno S, Cenerini G, Lo Giudice L, Cruz-Sanabria F, Benedetti D, Crippa A, Fiori S, Ferri R, Masi G, Faraguna U. Optimizing timing and dose of exogenous melatonin administration in neuropsychiatric pediatric populations: a meta-analysis on sleep outcomes. Sleep Med Rev. 2025 Dec;84:102158. doi: 10.1016/j.smrv.2025.102158. Epub 2025 Aug 30.
- Background: PubMed 38888087Cruz-Sanabria F, Bruno S, Crippa A, Frumento P, Scarselli M, Skene DJ, Faraguna U. Optimizing the Time and Dose of Melatonin as a Sleep-Promoting Drug: A Systematic Review of Randomized Controlled Trials and Dose-Response Meta-Analysis. J Pineal Res. 2024 Aug;76(5):e12985. doi: 10.1111/jpi.12985.
- Individual participant dataSharing planned: No. The data cannot be shared publicly for the privacy of individuals who participated in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mel 2 mg 30 min, Mel 2 mg 3 h and Mel 4 mg 30 min in people with Sleep Disorders, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ugo Faraguna, MD, PhD (+39 050 2213470, ugo.faraguna@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Latency (time frame: First night following administration of the drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07514507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.